The present invention relates to the control of nighttime hypoglycemia in diabetics who require insulin injections. The invention utilizes a food bar which can be administered at bedtime to control blood glucose levels.
The results of a major study (Diabetes Control and Complication Trial)(Dawson, Clinical Diabetes 11:88-96, 1993), including over 1,400 diabetic patients who require regular insulin administrations, have indicated that patients who maintain blood sugar levels as close as possible to normal have fewer complications resulting in neuropathy, retinopathy, and kidney disease. To accomplish this result, many patients with diabetes today follow a strict regimen, known as the "tight control" regimen. This regimen requires that the patients closely monitor their blood sugar levels (e.g., multiple tests/day), judiciously use insulin in multiple doses, and strictly adhere to their diet. The unwanted side effect of tight glucose control is, however, that patients following this regimen have a three-fold increase in hypoglycemic events, more than half of which occur at nighttime.
Hypoglycemia is a dangerous condition which develops quickly and can cause neurologic damage as well as cause a patient to go into an unconscious state, and, in rare instances, a coma. Physicians want patients to be aware of the symptoms of hypoglycemia, e.g., coldness, shakiness, palpitations, and altered mentation, in order to avoid this condition. However, during sleep, the patients are not aware that they are developing hypoglycemia, so it is crucial to develop a treatment which can prevent this condition from developing at nighttime.
Today, patients with diabetes usually take a snack before they retire at night in attempt to avoid hypoglycemia in conjunction with a nighttime injection of insulin. The insulin is administered in order to keep the blood sugar level as close to normal as possible during sleep. Traditional snacks available today provide a carbohydrate source (usually sucrose and complex carboxydrates) which is released into the bloodstream after ingestion and is taken up by cells under the influence of insulin for use as energy or storage in the form of glycogen or fat. Because of the rapid release of some of these forms of carbohydrate into the bloodstream after the ingestion, some active insulin is left over in the body during the remainder of the night. This left over insulin has no more sources of carbohydrate to interact with due to a reduction in glucose release, thus resulting in nighttime hypoglycemia.
Thus, a need still exists for an improved bedtime snack which can provide a continual release of glucose during the nighttime into the bloodstream to interact with insulin, thereby maintaining normal glucose levels, and can prevent nighttime hypoglycemia in diabetic patients.
Accordingly, an object of the invention is to provide a novel diabetic supplement bar which allows constant bloodstream glucose level during the night, thus preventing nighttime hypoglycemia in a diabetic patient.
Another object of the invention is to provide a method of preventing or treating nighttime hypoglycemia in a diabetic patient by administering the diabetic supplement bar of the invention.
A further object of the invention is to control nighttime blood sugar levels of diabetic patients by administering the diabetic supplement bar of the invention near bedtime which provides phased release of glucose in the bloodstream.
These and other objects and features of the invention will be apparent from the following description and from the claims.